This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the cobas 4800 braf v600 mutation test. This device is indicated for: the cobas 4800 braf v600 mutation test is an in vitro diagnostic device intended for the qualitative detection of the braf v600e mutation in dna extracted from formalin-fixed, paraffin-embedded human melanoma tissue. The cobas 4800 braf v600 mutation test is a real-time pcr test on the cobas 4800 system, and is intended to be used as an aid in selecting melanoma patients whose tumors carry the braf v600e mutation for treatment with vemurafenib.
| Device | COBAS 4800 BRAF V600 MUTATION TEST |
| Classification Name | Somatic Gene Mutation Detection System |
| Generic Name | Somatic Gene Mutation Detection System |
| Applicant | Roche Molecular Systems, Inc. |
| Date Received | 2011-04-25 |
| Decision Date | 2011-08-17 |
| Notice Date | 2011-08-19 |
| PMA | P110020 |
| Supplement | S |
| Product Code | OWD |
| Docket Number | 11M-0601 |
| Advisory Committee | Pathology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Roche Molecular Systems, Inc. 4300 Hacienda Drive pleasanton, CA 94588-2722 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P110020 | Original Filing | |
| S037 | 2022-10-21 | 30-day Notice |
| S036 | ||
| S035 | 2020-07-27 | 30-day Notice |
| S034 | 2019-09-20 | 30-day Notice |
| S033 | 2019-06-27 | Real-time Process |
| S032 | 2019-04-24 | 30-day Notice |
| S031 | 2018-11-13 | 30-day Notice |
| S030 | 2018-11-09 | 30-day Notice |
| S029 | 2018-08-21 | 30-day Notice |
| S028 | 2018-07-27 | 30-day Notice |
| S027 | 2018-06-29 | 30-day Notice |
| S026 | 2018-06-08 | 30-day Notice |
| S025 | 2018-06-04 | 30-day Notice |
| S024 | 2018-03-01 | 30-day Notice |
| S023 | 2017-10-30 | 30-day Notice |
| S022 | 2017-09-26 | 30-day Notice |
| S021 | 2017-07-17 | 30-day Notice |
| S020 | 2017-07-14 | 30-day Notice |
| S019 | 2017-07-14 | 30-day Notice |
| S018 | 2016-08-22 | 30-day Notice |
| S017 | 2016-07-08 | 30-day Notice |
| S016 | 2016-06-30 | Normal 180 Day Track |
| S015 | 2016-04-18 | 30-day Notice |
| S014 | 2015-06-24 | 30-day Notice |
| S013 | 2015-03-13 | 30-day Notice |
| S012 | 2014-12-19 | 30-day Notice |
| S011 | 2013-12-13 | 30-day Notice |
| S010 | 2013-12-13 | Real-time Process |
| S009 | 2013-08-14 | 30-day Notice |
| S008 | 2013-08-09 | 30-day Notice |
| S007 | 2013-07-26 | 30-day Notice |
| S006 | 2012-09-12 | Normal 180 Day Track |
| S005 | 2012-08-15 | 30-day Notice |
| S004 | 2012-07-02 | Real-time Process |
| S003 | 2011-12-12 | 135 Review Track For 30-day Notice |
| S002 | 2011-09-29 | 30-day Notice |
| S001 | 2011-09-19 | 30-day Notice |